EMA – Page 145 – Pharma.Tips

CCIT failure during stability pull: FDA/EMA investigation expectations

“`html Addressing Failures in CCIT During Stability Pull: Insights for FDA and EMA Compliance In the realm of pharmaceutical manufacturing, particularly in the production of ophthalmic and otic products, a…

Biosimilar aggregate level increase after manufacturing site change: how to build a defensible similarity narrative with data integrity controls

Identifying and Addressing Increased Biosimilar Aggregate Levels Post-Manufacturing Site Change The transition to a new manufacturing site can trigger numerous process-related challenges, especially in the biopharmaceutical sector. One critical issue…

Half-life deviation during radiopharma production: regulatory deviation handling

Addressing Half-life Deviation During Radiopharmaceutical Production: A Comprehensive Investigation Approach In the pharmaceutical manufacturing sector, especially within the realm of radiopharmaceuticals, production integrity is of paramount importance. One critical aspect…

Fill volume variability during inspection readiness: batch disposition and patient risk assessment

Understanding Fill Volume Variability During Inspection Readiness: Batch Disposition and Patient Risk Assessment In pharmaceutical manufacturing, particularly within the ophthalmic and otic product categories, fill volume variability can significantly impact…

Biosimilar residual HCP / DNA OOS during BLA/MAA review: bridging study planning and regulatory communication strategy

“`html Biosimilar Residual HCP/DNA Out-of-Specification Findings During BLA/MAA Review: Planning for Investigation and Regulatory Communication The emergence of biosimilars has revolutionized therapeutic treatments, but with it comes the inherent complexities…

Method variability OOS during small-batch manufacturing: risk-based GMP justification

Investigating Method Variability During OOS in Small-Batch Pharmaceutical Manufacturing In the complex environment of small-batch pharmaceutical manufacturing, method variability can lead to out-of-specification (OOS) results. These occurrences challenge manufacturers to…

PET failure during aseptic filling: CAPA and sterility assurance controls

Addressing PET Failure in Aseptic Filling: A Comprehensive Investigation Approach Plastic-ethylene-terephthalate (PET) containers are extensively utilized in pharmaceutical manufacturing, especially in aseptic filling processes for ophthalmic and otic products. When…

Biosimilar residual HCP / DNA OOS during comparability protocol execution: decision tree for lab method variability vs true product differences

Biosimilar Residual HCP / DNA OOS During Comparability Protocol Execution: An Investigation Framework In the complex landscape of biosimilar development, the occurrence of out-of-specification (OOS) results for residual host cell…

Specification justification gap during lifecycle management: FDA/EMA communication strategy

Addressing Specification Justification Gaps in Lifecycle Management: A Framework for Investigation In pharmaceutical manufacturing, the lifecycle management of product specifications is crucial for regulatory compliance and maintaining product quality. However,…

Sterility test failure during stability pull: batch disposition and patient risk assessment

Sterility Testing Failures During Stability Pull: Navigating Batch Disposition and Risk Assessment In pharmaceutical manufacturing, a sterility test failure during a stability pull can trigger a series of rigorous investigations…

Biosimilar glycan profile mismatch during BLA/MAA review: how to build a defensible similarity narrative with data integrity controls

Addressing Mismatches in Biosimilar Glycan Profiles During BLA/MAA Reviews: A Comprehensive Investigation Approach Biosimilar development is a complex process, demanding high levels of data integrity to ensure compliance with regulatory…

Specification justification gap during lifecycle management: risk-based GMP justification

Addressing Specification Justification Gaps During Lifecycle Management in Pharma Manufacturing Specification justification gaps can pose significant challenges in the pharmaceutical manufacturing realm, particularly as products transition through various lifecycle stages.…